ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity

Recruiting at 1 trial location

Overseen By Teo Uysal

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ERX Pharmaceuticals

Must not be taking: Weight loss drugs

Disqualifiers: Metabolic disorders, Liver disease, others

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol suggests that you may need to stop taking certain medications, especially those that could affect drug absorption, metabolism, or elimination, as well as any prescription or nonprescription medications, vitamins, or supplements, unless approved by the study doctor. It's best to discuss your specific medications with the study team to see if they are allowed.

What safety data exists for the treatment known as ERX1000, Placebo, Control, or Dummy Treatment?

The safety data for treatments like ERX1000, Placebo, Control, or Dummy Treatment often includes reports of adverse events (unwanted effects) even when no active drug is given. In studies with healthy volunteers, common side effects reported with placebos include headaches, drowsiness, and weakness, with about 19% of participants experiencing these effects. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new oral medication called ERX1000 to see if it is safe and can be tolerated by people who are obese.

Research Team

Irene Mirkin, MD

Principal Investigator

Labcorp Clinical Research Unit Inc.

Eligibility Criteria

Inclusion Criteria

The person is able to understand the information in the consent form and is willing to abide by the study restrictions.

The systolic blood pressure is between 90 and 140 mmHg.

The subject is determined to be in good health if there are no clinically significant findings from the subject's medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in.

Exclusion Criteria

Donation of blood from 8 weeks prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.

Consumption of alcohol from 72 hours prior to Check-in.

Use of tobacco- or nicotine-containing products (including nicotine and non-nicotine e-cigarettes, vaping, etc.) within 3 months prior to Check-in, or positive cotinine at Screening or Check-in.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive single oral doses of ERX1000 or placebo to assess safety and tolerability

4 weeks

Treatment Part B

Participants receive multiple oral doses of ERX1000 or placebo to assess safety and tolerability

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ERX1000
• Placebo

Participant Groups

Group I: ERX1000 Experimental Treatment 1 Intervention

ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension Proposed dose level for Part A: 4 mg and 8 mg Proposed dose level for Part B: 4 and 8 mg. The dose administered will not exceed the highest dose administered in Part A.

Group II: Placebo Placebo Group 1 Intervention

Reference product: Magnesium hydroxide carbonate powder prepared in an oral suspension

Who Is Running the Clinical Trial?

ERX Pharmaceuticals

Lead Sponsor

Trials

1

Recruited

50+

Findings from Research

Adverse events (AEs) are reported in 49.1% of trial participants in placebo groups, indicating that these events are quite common and not solely due to the natural progression of conditions.

The prevalence of AEs in placebo groups (6.51%) is higher than in untreated groups (4.25%), suggesting that the nocebo effect may play a significant role in the experience of AEs during clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. Howick, J., Webster, R., Kirby, N., et al.[2022]

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

The Drug Adverse Reaction Database (DART) provides detailed information on 147 confirmed and 89 potential protein targets associated with adverse drug reactions (ADRs), which is crucial for understanding the mechanisms behind these reactions and aiding in drug discovery.

DART includes extensive data on 257 drugs and 1080 ligands, offering insights into their binding properties, physiological functions, and the specific adverse effects they may cause, making it a valuable resource for researchers and developers in pharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. Ji, ZL., Han, LY., Yap, CW., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The SIDER database of drugs and side effects. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. [2018]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. [2019]